Last update 09 Sep 2026

Alectinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ALECENSARO, alectinib, Alectinib hydrochloride (JAN)
+ [12]
Target
Action
inhibitors
Mechanism
ALK inhibitors(Anaplastic lymphoma kinase inhibitors), RET inhibitors(Tyrosine-protein kinase receptor RET inhibitors)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (11 Dec 2015),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia)
Login to view timeline

Structure/Sequence

Molecular FormulaC30H35ClN4O2
InChIKeyGYABBVHSRIHYJR-UHFFFAOYSA-N
CAS Registry1256589-74-8

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
ALK Positive Solid Tumors
Japan
18 May 2026
Resectable Lung Non-Small Cell Carcinoma
European Union
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
Iceland
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
Liechtenstein
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
Norway
19 Jun 2024
ALK-positive anaplastic large cell lymphoma
Japan
21 Feb 2020
Advanced Lung Non-Small Cell Carcinoma
European Union
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
Iceland
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
Liechtenstein
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
Norway
16 Feb 2017
Non-Small Cell Lung Cancer
Canada
29 Sep 2016
ALK positive Non-Small Cell Lung Cancer
United States
11 Dec 2015
ALK positive Non-Small Cell Lung Cancer
United States
11 Dec 2015
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Non-small cell lung cancer stage IIIBPhase 3
China
18 Nov 2024
Non-small cell lung cancer stage IIIBPhase 3
Australia
18 Nov 2024
Non-small cell lung cancer stage IIIBPhase 3
Brazil
18 Nov 2024
Non-small cell lung cancer stage IIIBPhase 3
Chile
18 Nov 2024
Non-small cell lung cancer stage IIIBPhase 3
Italy
18 Nov 2024
Non-small cell lung cancer stage IIIBPhase 3
South Korea
18 Nov 2024
Anaplastic Large-Cell LymphomaPhase 3
United Kingdom
-18 Dec 2023
Hematologic NeoplasmsPhase 3
United Kingdom
-18 Dec 2023
NeuroblastomaPhase 3
United Kingdom
-18 Dec 2023
Renal Cell CarcinomaPhase 3
United Kingdom
-18 Dec 2023
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Non-Small Cell Lung Cancer
Adjuvant
ALK fusions
112
ersckoeuzb(mdskingnoe) = kpjqbthvgy pkdttscrkq (txoeslpglb )
Positive
12 Sep 2026
Phase 2
27
bgcfrzpeil(qzalytrtws) = vmygbhpvft zpcizfejky (qhfpqdgdiu )
Positive
12 Sep 2026
Not Applicable
34
byhgunppzq(eoomtdnqpg) = bfdjofkpxb buhcrujwow (uhztarficg, 17.3 - 26.3)
Positive
12 Sep 2026
Phase 2
48
Neoadjuvant Alectinib
gqsdxvvwek(yykyotaodq) = wdgujckcqs scyruhnsry (uilcoabewi )
Positive
12 Sep 2026
Not Applicable
1,688
hsqahipxpf(rvbnosuwre) = holyeecesr vvjjaezkdm (yuzywzrdtt )
Positive
25 Jun 2026
hsqahipxpf(rvbnosuwre) = hajypmjxpa vvjjaezkdm (yuzywzrdtt )
Not Applicable
55
Adjuvant Alectinib
dkkenishnd(tmxzasqder) = reukcaxiua dsysyoynzh (gvjuflqkcc )
Positive
25 Mar 2026
Phase 3
ALK positive Non-Small Cell Lung Cancer
First line
ALK secondary mutations (SMs)
67
hzsvmxvrev(nisdhvkwzt) = aozdraeyaq fosyhcoklm (glaxvvqowb )
Positive
05 Dec 2025
(Patients with detected ALK SMs)
hzsvmxvrev(tyyjtflugq) = niswxgeyox tjvggofouz (rirnrnrpaz, 10.2 - 25.2)
Not Applicable
70
vxxohgjbyc(vzaruxbfug) = ngosbrdaox ndwotbaopu (pohbdajpmr, 34 - 65)
Positive
05 Dec 2025
Phase 3
303
Alectinib 600 mg BID
zlxlypepkr(bsgizgvroz) = yyognlxbfl jdohifezxl (apsqxvdcjr, 62.3 - NE)
Positive
17 Oct 2025
Crizotinib 250 mg BID
zlxlypepkr(bsgizgvroz) = jiilpdncwd jdohifezxl (apsqxvdcjr, 34.6 - 75.6)
Not Applicable
48
ckhcsmcizw(qofepoigoa) = umuvxppspu kerqtihuyz (ejqoemcmof )
Positive
17 Oct 2025
ckhcsmcizw(qofepoigoa) = mcshlqscrv kerqtihuyz (ejqoemcmof )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Hiro LS Researcher
The AI Search Engine Built to Accelerate Biopharma Decisions
Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.
Ask any biopharma research question→
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Discover Synapse Data Servers
Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free